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The CRT-KIR Study (Cardiac Resynchronization Therapy [CRT] in the Early Phase After Heart Surgery)

Primary Purpose

Bundle-Branch Block

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Temporary cardiac resynchronization therapy
Sponsored by
Rigshospitalet, Denmark
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bundle-Branch Block focused on measuring Cardiac resynchronization, Heart failure, open heart surgery, surgery

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patient scheduled for open heart surgery (coronary artery bypass graft [CABG] or mitral valve surgery or aortic valve surgery or combinations of the above mentioned surgical procedures) and LV ejection fraction < 35% and bundle branch block (QRS > 9.12 s) Exclusion Criteria: Severe right heart failure Permanent atrial fibrillation Congenital heart disease Serious non-cardiac disease

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Non invasive cardiac output after 72 hours CRT (versus control) treatment

    Secondary Outcome Measures

    Echocardiographic measures of left ventricular (LV) function
    Mixed venous oxygen saturation
    Invasively determined cardiac output
    Plasma brain natriuretic peptide (p-BNP)
    Number of hours with inotropic treatment

    Full Information

    First Posted
    September 11, 2005
    Last Updated
    July 9, 2007
    Sponsor
    Rigshospitalet, Denmark
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00192946
    Brief Title
    The CRT-KIR Study (Cardiac Resynchronization Therapy [CRT] in the Early Phase After Heart Surgery)
    Official Title
    Cardiac Resynchronization Therapy (CRT) in the Early Phase After Heart Surgery
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2006
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    The study population is smaller than expected. No subjects were included.
    Study Start Date
    undefined (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    September 2008 (Anticipated)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Rigshospitalet, Denmark

    4. Oversight

    5. Study Description

    Brief Summary
    In patients with broad QRS complexes on electrocardiogram (ECG), the delayed electrical activation of the left heart chamber will cause abnormal contraction.This has been shown to be possible to treat by a special pacemaker treatment which includes pacing of the left heart chamber (= CRT treatment). In this study the researchers will investigate the effect of acute CRT treatment in the early phase after open heart surgery.
    Detailed Description
    Patients with bundle branch block have a delayed electrical activation of the left ventricle causing abnormal contractility of the left ventricle. We hypothesize that patients may benefit from short term (= 72 hours) CRT (Cardiac Resynchronization Therapy) in the early phase after open heart surgery. Patients: reduced LV function and bundle branch block. Study type: randomisation to CRT versus standard postoperative treatment Study variables: cardiac output, echocardiographic measures, p-BNP and hours with inotropic therapy.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Bundle-Branch Block
    Keywords
    Cardiac resynchronization, Heart failure, open heart surgery, surgery

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Intervention Type
    Procedure
    Intervention Name(s)
    Temporary cardiac resynchronization therapy
    Primary Outcome Measure Information:
    Title
    Non invasive cardiac output after 72 hours CRT (versus control) treatment
    Secondary Outcome Measure Information:
    Title
    Echocardiographic measures of left ventricular (LV) function
    Title
    Mixed venous oxygen saturation
    Title
    Invasively determined cardiac output
    Title
    Plasma brain natriuretic peptide (p-BNP)
    Title
    Number of hours with inotropic treatment

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patient scheduled for open heart surgery (coronary artery bypass graft [CABG] or mitral valve surgery or aortic valve surgery or combinations of the above mentioned surgical procedures) and LV ejection fraction < 35% and bundle branch block (QRS > 9.12 s) Exclusion Criteria: Severe right heart failure Permanent atrial fibrillation Congenital heart disease Serious non-cardiac disease
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Jesper H Svendsen, MD
    Organizational Affiliation
    Rigshospitalet, Denmark
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

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    The CRT-KIR Study (Cardiac Resynchronization Therapy [CRT] in the Early Phase After Heart Surgery)

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